HospitalInspections.org

Based on interview and record review, the facility failed to

A. provide Important Message from Medicare (IMM) Form within 2 days of admission and before discharge in 5 (Patient #1, 2, 3, 6, and 7) of 5 charts reviewed.

Refer to A0117

B. include the patients representative in development of the plan of care, during the weekly care planning meeting from 11/27/2021 through 12/13/2021, for 3 of 3 patients (Patient #1, #8 and #9)reviewed.

Refer to A0130


C. ensure informed consent to treatment and care for a voluntary admission was signed and understood by a competent adult that had the capacity to consent in 5 (Patient #1, 2, 3, 6, and 7) of 5 charts reviewed.

D. ensure the patients consented and received an explanation by the nurse or physician the name of administered psychotropic medications, the beneficial effects on the patient's mental illness, or condition expected as a result of treatment with psychotropic medication in 5 (Patient #1, 2, 3, 6, and 7) of 5 charts reviewed.

Refer to A0131

E. ensure pt #1's right to privacy on 12/6, 12/7, 12/8 and 12/11/ of 2021, Pt #8's rights on 6/30/2022 the date of her admission, when the nursing staff placed their respective bed in the common hallway to ensure close monitoring while sleeping from 11/27/2021 through 12/13/2021 and 6/30/2022.

Refer to A0143

F. ensure the nursing staff of the Behavioral Health Unit documented, evaluated and assessed patient's loud, wandering, disruptive behavior, and failed to ensure the nursing staff attempted intervention other than redirection such as (place patient on 1:1 status, remove patient to quiet room, attempt oral medication) prior to notifying the psychiatrist for intramuscular medication (IM) for 3 of 3 patients (Patient #1, #8 and #9) from 11/27/2021 through 6/8/2022.

Refer to A0144

G. recognize that medications administered to restrain a patient behavior, resulting in restricting the patient's freedom of movement, was a Chemical Restraint/Emergency Behavioral Medication (EBM) administration and was prohibited to be written as a PRN (as needed) order in 1 of 1(#1) patient charts reviewed.

H. ensure patient safety when administering sedative and psychotropic medications to control immediate behavioral emergencies. The facility failed to recognize emergency behavioral medications were chemical restraints and not therapeutic treatment in 3 of 3 (#1, #3 and #6) patient charts reviewed.

I. ensure staff conducted comprehensive patient assessments with escalation of behavior to determine patient needs and interventions prior to the administration of chemical restraints/emergency behavioral medication, and continuous monitoring after administering a chemical restraint/emergency behavioral medication for side effects, respiratory or cardiac distress, and assessment of medication effectiveness and safety after administration in 3 of 3 (#1, 3 and 6) patient charts reviewed.

J. ensure a face-to-face evaluation was conducted following the administration of a chemical restraint/emergency behavioral medication to 3 of 3 (#1, #3 and 6) patient charts reviewed. The face-to-face evaluation should be conducted within 1 hour of the restraint to determine the patient's immediate situation, patient's response to the restraint, and patient's medical and behavioral condition.

Refer to A0160

Based on record review and interview, the facility failed to provide Important Message from Medicare (IMM) Form within 2 days of admission and before discharge in 5 (Patient #1, 2, 3, 6, and 7) of 5 charts reviewed.

Review of Patient charts #1,2,3,6,and 7 revealed the patients were given their Important Message from Medicare (IMM) upon admission but did not receive the second copy before discharge.

An interview with Staff # 2 and #3 was conducted on 7/11/22 in the afternoon. Staff #2 and #3 stated they were not aware that the 2nd IMM letter was to be delivered to the patient.

Based on interview and record review, the facility failed to include the patients representative in development of the plan of care and weekly care planning meeting, from 11/27/2021 through 12/13/2021, for 3 of 3 patients (Patient #1, #8 and #9).


This deficient practice had the likelihood to effect all patients of the Behavioral Health Unit (BHU) of the hospital.


Findings included

On 7/8/2022, prior to the onsite investigation, the family of pt#1 was contacted by phone. During the discussion the family was asked, "Did you participated in a care planning meeting"? The family stated, "The Psychiatrist called and told us what the plan was". The family went on to describe how they had asked the Psychiatrist, what would the facility do when pt #1 began to push away the staff, when assistance was offered. The family stated,"The Psychiatrist said, "They would give him a shot".

On the morning of 7/11/2021 an interview with staff #3, the Registered Nurse Manager of the BHU confirmed, families were not notified of the care planning meetings or expected to participate. She said to her knowledge none of the nursing staff communicated with the families regarding the plan of care for the patients. This would include patient's #8 and #9.

Further questioning confirmed the Psychiatrist called once, and the Social Worker called regarding discharge planning. Once a nurse called to say, "He was not doing well and it they wanted to see him they should ask the doctor for an emergency visit." The nurses did not regularly call.

Review of the medical record (MR) confirmed, the admission treatment plan documented by staff Psychiatrist #7 was, "Treatment plan: Goal in treatment is to stabilize his mood, eliminate the psychosis, reduce the agitation and aggression and improve his reality based thinking. Medications and psychotherapy, including individual, group and activity therapy will be utilized to achieve relief from symptoms and improve illness, management skills, coping skills and overall functioning".

Further review identified 11/29/2021, staff Psychiatrist #7 documented, (2 days after admission), "Patient is very confused and disoriented. He is distracted and responding to internal stimuli. He is not able to verbalize his needs. He attends groups but his participation is minimal to none. Last night he received Geodon IM for agitation. He was very restless, repeatedly trying to get out of bed, hallucinating, mumbling and getting agitated with
staff. Today he received Geodon IM after lunch, he was very restless, tried to hit staff.
He is compliant with oral medications. He tolerated medications without any side effects. He slept 6 hours 15 minutes last night. His appetite is fair. He needs assistance and cues with activities of daily living. His strengths include good premorbid functioning and good primary support. His weakness includes cognitive decline and medical problems".

Pt #1 was exhibiting inability to participate in psycho-therapy, the family was not notified pt #1 was not participating in the psycho-therapy or that the medication plan of care changed. The family was not made aware that intramscular (IM) Geodon had be added, beginning 11/27/2021 the evening after admission.

A review of the consents signed by pt #1's wife on 11/27/20 included,"Geodon" (Ziprasidone). An interview with pt #1's wife confirmed she was asked to sign the consent, The copy of the signed consent was dated and timed, on 11/27/2021 at 1420. The psychiatrist wrote the first order for Geodon IM on 11/27/2021 at 1756. The Registered Nurse had pt #1's wife sign the consent for the use of IM Geodon at the time of admission.

On 7/15/2022 an interview with family members confirmed no Behavioral Health Unit (BHU) staff notified them of violent or aggressive behavior requiring the use of IM Geodon.

A review of the MR confirmed beginning 11/27/2021, the date of admission until 12/13/2021, the date of discharge pt #1 received 9 doses of IM Geodon.

Review of the MR confirmed pt #1 was documented as "asleep" from 12/10/2021 at 7:00 PM until 9:45 AM on 12/12/2021, with only 2.5 hours of intermittent awake time. Review of the medical record reflected no documentation of communication with the family.

Interview on 7/15/2022 with the family confirmed an unidentified RN called 12/12/2021 to tell them, "He (Pt #1) was not doing well and if they wanted to see him they should ask the Dr for an emergency visit."

Further review of the MR confirmed the Registered Dietician (RD) documented the following, "Patient qualifies for mild to moderate malnutrition as evidenced by weight (wt) loss 23 lbs. Over past 12-18 months (14%) with mild to moderate subcutaneous fat losses and muscle wasting and intake <50% EER (estimated energy requirement) over past 5 days". The RD neglected to take into account pt#1 had been asleep for much of the past 5 days.

Interview on 7/15/2022 with the family confirmed, "Pt #1 had lost no measurable wt. prior to admission to the BHU. He had a great appetite. Pt #1 had been seen in person by his primary care physician, Staff #8, only 1 time in the past 1.5 years related to COVID-19"."The visit was not related to wt loss".

On 7/11/2022 staff #2 the Chief Nursing Officer (CNO) and Staff #3 the RN manager for the BHU were asked, "Where did the RD acquire her information, that the patient had suffered a 23 pound weight loss over the past 12-18 months"? The response was, "I don't know". A review of the MR confirmed pt #1 was not able to answer questions, the PCP had not seen the pt in a year and half prior to admission into the BHU. Interview with the family confirmed they had not been contacted by the RD for information regarding his pre-admission weight or appetite.

MR documentation confirmed the family was not involved in the plan of care for pt #1 after admission. The BHU staff had failed to communicate with the family regarding behaviors requiring IM medication. Pt #1's increased sleep and therefore decreased nutritional intake, which supported pt #1's wt. loss 12.34 pounds from the date of admission, was not communicated to the family.

Review of pt #8 and pt #9's MR confirmed no nursing documentation their family was notified of changes in health or behavior. Their was no documentation their families were included in the care planning meeting or care planning process.

Based on record review and interview the facility failed to:

A. ensure informed consent to treatment and care for a voluntary admission, was signed, and understood by a competent adult that had the capacity to consent in 5 (Patient #1, 2, 3, 6, and 7) of 5 charts reviewed.

B. ensure the patients consented and received an explanation by the nurse or physician the name of administered psychotropic medications, the beneficial effects on the patient's mental illness, or condition expected as a result of treatment with psychotropic medication in 5 (Patient #1, 2, 3, 6, and 7) of 5 charts reviewed.

Patient #1

Review of the chart revealed Patient #1 was admitted to the facility on 11-27-21 at 1420 (2:20PM). Review of the chart revealed there was no order by a physician for voluntary or involuntary status. There was an Emergency Detention Warrant (EDW) started by the admissions nurse but was never signed by a Justice of the Peace or County Judge. There was no evidence of any viable type of warrant. The spouse of Patient #1 stated that she was told he would be there voluntarily. There was no Guardianship or LAR appointed for this patient.

Review of the policy and procedure "BHU Procedure for Voluntary and involuntary Admission Process" stated,
"DEFINITIONS
A patient who has the capacity to consent and meets criteria may voluntarily admit themselves to a psychiatric unit.
A patient who refuses to admit self to enter treatment, but who is admitted under the authority of a legal instrument issued by a Court of Law having proper jurisdiction in the matter of involuntary commitment proceedings in the State is considered an involuntary patient."

Review of Patient #1's chart revealed the following admission consents were not signed by the patient but by his wife on 11-27-21 at 1420 (2:20PM):
General Consent for Treatment
Patient Bill of Rights
Consent to Treatment w/Psychoactive Medications
Consent for Telemedicine
Information Practices
Important Message from Medicare
Visitation and Telephone Consent
Photographs

Review of the psychiatrist evaluation dated 11-27-21 stated, "History of present illness: Patient is an 83-year-old white male with dementia. He is being admitted from home with psychotic symptoms and behavior disturbances. He is agitated and acting out. He is responding to internal stimuli. He has visual hallucinations of people. He is looking for his dead parents. He resists assistance and is combative with his caregivers. He is labile, with mood swings and outbursts. He is not able to attend or concentrate. He is not able to follow directions. Sleep and appetite disturbances are also reported."

Review of Patient #1's chart revealed the nursing admission assessment completed on 11-27-22 at 1601 (4:01PM) stated, "insight not appropriate to situation, judgment not appropriate to situation." Review of the nursing flowsheet on 11/27/21 @ 2332 under orientation, the nurse wrote, "disoriented to; place; time; situation."

Review of Patient #1's psychotropic medication consents revealed 4 medications (Zyprexa, Gabapentin, Geodon and Seroquel) consents were all signed on 11/27/21 at 1420 (2:40PM) by an LVN and the patient's wife.
Patient #1 was administered medication without his informed consent, without a court order while he was admitted to the facility from 11/27/2021 to 12/13/2021. Patient #1 was his own guardian and was not subject to a court-ordered medication. He was administered an IM psychotropic medication without justifying the use of an involuntary medication. Patient #1 was given IM Geodon for behaviors, but the facility failed to recognize the medication administration as an Emergency Behavioral Medication (EBM).

Persons receiving mental health services have" the right to be free from unnecessary or excessive medication, which includes the right to give or withhold informed consent to treatment with psychoactive medication, unless the right has been limited by court order or in an emergency."

See 25 TEX. ADMIN. CODE§ 404.154(16); see also TEX. HEALTH & SAFETY CODE§ 576.02l(a). In
Texas, in the absence of consent by a guardian, authorization by a court order, or a behavioral health emergency, psychoactive medications can be administered only with informed consent. For a patient's consent to be "informed," staff at facility's mental health unit are required to not only provide certain information to the patient or their consentor, but also to obtain written consent "evidenced in the patient's clinical record by a signed form." TEX. HEALTH & SAFETY CODE§ 576.025(b)(4); see also 25 TEX. ADMIN. CODE§ 414.405.


Patient #6

Review of Patient #6's chart revealed she was admitted on 5/7/22 with a diagnosis of Dementia with behavioral disturbance. Patient #6 had an OPC on the chart but was not signed until 5/9/22 by the county judge. There was no application or order for forced medications. There was no physician order for voluntary or involuntary status. Review of the chart revealed there was no documentation of a Guardianship or Mental Health POA.

Review of the Psychiatric Evaluation dated 5/7/2022 9:51 PM the physician documented, "History of present illness Patient is a 73-year-old white female with dementia. She is being admitted from assisted living facility with psychotic symptoms and behavior disturbances. She is labile with mood swings and outbursts. She is not able to attend or concentrate. She is not able to follow directions. She is pacing and wandering. She is repeatedly trying to leave the facility. She was refusing her medications and refusing to eat ...She is oriented to self only. Memory is impaired."

Review of Patient #6's chart revealed the following admission consents were signed by two nurses and the consents stated the spouse gave consent via phone on 5/6/22 at 2045 (8:45PM). The Patient was documented as being admitted into the facility on 05/07/22 0054.
General Consent for Treatment
Patient Bill of Rights
Consent to Treatment w/Psychoactive Medications
Consent for Telemedicine
Information Practices
Important Message from Medicare
Visitation and Telephone Consent
Photographs

Review of Patient #6's psychotropic medication consents revealed 6 medications (Zyprexa, Geodon, Aricept, Memantine, and Seroquel, Neurontin) consents were all signed on the following dates:
Zyprexa 5/21/22 at 12:55PM by spouse.
Seroquel 5/7/22 by two nurses at 1529. Stated phone consent by spouse.
Neurontin 5/21/22 12:55PM by spouse.
Aricept 5/7/22 at 1530 by spouse.
Memantine 5/7/22 at 1530 by spouse.
Geodon 5/7/22 at 1258 by spouse.

Patient #6 received Ativan IM on 05/09/22 0934 with no consent and no documentation of an EBM.
Patient #6 was administered medication without her informed consent, without a court order for forced medications while she was admitted to the facility from 5/7/22 to 5/31/22. Patient #6 was not subject to a court-ordered medication. She was administered an IM psychotropic medication without justifying the use of an involuntary medication. Patient #6 was given IM Geodon and Ativan for behaviors, but the facility failed to recognize the medication administration as an Emergency Behavioral Medication (EBM).

Patient #2

Review of Patient #2's chart revealed she was admitted to the facility on 11/24/21 at 1550 (3:50PM) with a diagnosis of Dementia with Behavioral Disturbances.

Review of Patient #2's chart revealed the psychiatrist initial exam was performed on 11/25/2021 at 1755 (5:55PM). The physician documented,
"Mental status examination
Blood pressure 115/80. Pulse 89.
71-year-old female appears stated age. Eye contact is poor. She is somewhat disheveled. Behavior is uncooperative, irritable, hostile, restless. Muscle strength and tone are normal. No abnormal movements. She uses a walker to ambulate. Speech is spontaneous, disorganized with significant poverty of content. She responds with "I do not know" to most questions. Articulation is mumbled. Thought processes are concrete. Associations are loose. Thought content is prominent for delusions and hallucinations as reported in history of present illness. No suicidal or homicidal ideations. She is oriented to self only. Memory is impaired. Attention span and concentration are short and distracted. She is aphasic. She is not able to name objects or repeat phrases. Insight and judgment are impaired."

Review of Patient #2's chart revealed the following admission consents were not signed by the patient but by two nurse signatures on the consents. The following consents stated the spouse gave verbal consent over the telephone on 11-24-21 at 1550 (3:50PM):
General Consent for Treatment
Patient Bill of Rights
Consent to Treatment w/Psychoactive Medications
Consent for Telemedicine
Information Practices
Important Message from Medicare
Visitation and Telephone Consent
Photographs

Review of the chart revealed Patient #2 had a Durable Medical Power of Attorney. Review of Patient #2's DPOA revealed it was for financial issues only. The patient's chart did not have a Guardianship or Mental Health Power of Attorney to consent for treatment.

Consents would not be required for patient signatures due to the Emergency Detention Warrant (EDW) found on the patient's chart dated 11/24/21. However, the psychiatrist saw the patient on 11/25/2021 at 1755 which would have ended the EDW. There was no order to hold the patient for the Order of Protective Custody (OPC) process or that her status was now changed to voluntary. If her status had been changed to a voluntary status the consents would need to be signed by the patient with a capacity to consent. AN EDW ends in 48 hours or when a physician exam is completed.

Review of the Texas Health and Safety code stated, "TITLE 7. MENTAL HEALTH AND INTELLECTUAL DISABILITY
SUBTITLE C. TEXAS MENTAL HEALTH CODE
CHAPTER 573. EMERGENCY DETENTION
SUBCHAPTER C. EMERGENCY DETENTION, RELEASE, AND RIGHTS
Sec. 573.021. PRELIMINARY EXAMINATION. ...
(b) A person accepted for a preliminary examination may be detained in custody for not longer than 48 hours after the time the person is presented to the facility unless a written order for protective custody is obtained. The 48-hour period allowed by this section includes any time the patient spends waiting in the facility for medical care before the person receives the preliminary examination."

Review of Patient #2's psychotropic medication consents revealed 10 medication consents (Ativan, Zyprexa, Geodon, Aricept, Clonazepam, Escitalopram, Clozapine, Memantine, Neurontin, and Seroquel) were all signed by two nurses from a phone consent or in person by the spouse. Patient #2 was administered medication without her informed consent, without a court order for forced medications while she was admitted to the facility from 11/24/2021 1558 to 01/27/2022 1120. Patient #2 was not subject to a court-ordered medication. She was administered IM psychotropic medication without justifying the use of an involuntary medication. Patient #2 was given IM Geodon for behaviors, but the facility failed to recognize the medication administration as an Emergency Behavioral Medication (EBM).

Patient # 7

Review of Patient #7's chart revealed she was admitted to the facility on 5/16/22 for Bipolar disorder, current episode manic severe with psychotic features. Review of the psychiatrist initial psychiatric evaluation dated 5/16/2022 at 2202 stated,

"Mental status examination
Blood pressure 115/87. Pulse 77.
79-year-old female appears stated age. Makes adequate eye contact. She is appropriately groomed. Behavior is cooperative but very restless and fidgety. Muscle strength and tone are normal. No abnormal movements. Gait and station are normal. Speech is spontaneous, hyper talkative, rapid, pressured with flight of ideas and multiple delusions. Thought processes are accelerated. Thought content is prominent for delusions as reported in history of present illness. No suicidal or homicidal ideations. She is oriented to person only. Cognitive functioning is impaired. Attention span and concentration are short and distracted. Language and fund of knowledge could not be tested. Mood is labile. Affect is appropriate. Insight and judgment are poor."

Review of Patient #7's chart revealed the following admission consents were not signed by the patient but by two nurse signatures on the consents. The following consents stated the son gave verbal consent over the telephone on 5-16-22 at 1300 (1:00PM):
General Consent for Treatment
Patient Bill of Rights
Consent to Treatment w/Psychoactive Medications
Consent for Telemedicine
Information Practices
Important Message from Medicare
Visitation and Telephone Consent
Photographs

Review of Patient #7's chart revealed there was no warrants to hold the patient, no found Guardianship or Mental Health Power of Attorney to consent for treatment, and no physician order to determine the patient's status of voluntary vs involuntary.

Review of Patient #7's psychotropic medication consents revealed 8 medication consents (Topamax, Zyprexa, Geodon, Clonazepam, Latuda, Trazadone, Neurontin, and Temazepam) were all signed by two nurses from a phone consent or in person by the son.

Patient #7 was administered medication without her informed consent, without a court order for forced medications while she was admitted to the facility from 05/16/2022 1611 to 06/09/2022 0949. Patient #7 was not subject to a court-ordered medication. She was administered IM psychotropic medication without justifying the use of an involuntary medication. Patient #7 was given IM Geodon for behaviors, but the facility failed to recognize the medication administration as an Emergency Behavioral Medication (EBM).

Patient #3

Review of Patient #3's chart revealed she was admitted to the facility on 5/19/22 at 1338 with a diagnosis of Dementia with Behavioral disturbances.

Review of the psychiatrist initial psychiatric evaluation dated 5/19/2022 at 5/19/2022 2358 stated, "Mental status examination 93-year-old female, appears stated age. Makes adequate eye contact. She is appropriately groomed, dressed in casual clothes. Behavior is uncooperative, irritable, restless, pacing, fidgety. Muscle strength and tone show general weakness. No abnormal movements. She has a stooped posture, gait is normal. Speech is spontaneous, hyper talkative, delusional content. Articulation is clear. Thought processes are concrete. Thought content is prominent for delusions and hallucinations as reported in history of present illness. No suicidal or homicidal ideations. She is oriented to person only. Memory is impaired. Attention span and concentration are short and distracted. Language and fund of knowledge could not be tested. Mood is labile. Affect is appropriate. Insight and judgment are impaired.

The patient had an OPC on the chart dated 5/20/22 there was no application or order for forced medications. Patient #3 still had the right to refuse medications and the facility was still required to obtain consents for psychotropic medications. Review of Patient #3's chart revealed she had 4 medication consents for (Gabapentin, Zyprexa, Seroquel, and Lorazepam.) The consents were signed by her grandson stating he was the POA. There was no DPOA, Guardianship, or Mental Health POA found.

Patient #3 was administered IM psychotropic medication without justifying the use of an involuntary medication. Patient #3 was given IM Ativan for behaviors, but the facility failed to recognize the medication administration as an Emergency Behavioral Medication (EBM).

An interview with Staff #2 and #3 was conducted on 7/11/22. Staff #2 confirmed that the facility had to receive or apply for a warrant to hold the patients in the facility. Staff #2 stated that she used to work on that unit and that was something she monitored closely to determine if the patient was sent for an OPC, if they were unable to consent, or determined by the physician and courts of incompetence. Staff #2 was not aware that the physician was not writing orders for legal status or that warrants were not completed or filed. Staff #3 and #2 denied any monitoring in quality for warrants or legal status orders.

Based on record review and interview, the facility failed to ensure pt #1's rights to privacy on 12/6, 12/7, 12/8 and 12/11/ of 2021, pt #8's rights on 6/30/2022 the date of her admission, when the nursing staff placed their respective bed in the common hallway to ensure close monitoring while sleeping from 11/27/2021 through 12/13/2021 and 6/30/2022.

This deficient practice had the likelihood to effect all patients of the Behavioral Health Unit of the hospital.

Findings included.

During the medical record (MR) review of 7/11/2022 of patient (Pt/pt) #1's MR documentation provided confirmed the nursing staff placed pt #1's bed in the hallway to keep him in line-of-sight while he was in bed. Pt #1 was a high fall risk. Documented times he was placed in the bed while in the hallway occurred on,

12/6/2021 0953-1100 "calm, in hallway in bed asleep".
12/7/2021 0857 "Calm in hallway asleep".
12/8/2021 0049 "Patient asleep in bed that has been placed in the hallway for close observation".
12/11/2021 0211 "Patient sleep in his bed that has been placed in the hallway for close observation due to high fall risk".

Review of the MR for Pt #8, "Behavior and mood: hitting staff, cursing, being rude, then become calm and quiet when you don't talk to her, patient now asleep in the hallway".

This evidence of documentation was provided by staff #5 and confirmed by staff #3.

Based on record review and interview the facility failed to ensure the nursing staff of the Behavioral Health Unit documented a) accurate transcribe, date, time and follow, "as needed (PRN)" physician orders, and b) evaluated and assessed patients beyond loud, wandering, disruptive behavior, before obtaining PRN Physician orders for Intramuscular Ziprasidone (Geodon) for use in control of dementia patients for 3 of 3 patients (Patient #1, #8 and #9 from 11/27/2021 through 6/8/2022.

This deficient practice had the likelihood to affect all patients of the Behavioral Heath Unit of the hospital.

Findings included.



Pt #1
Pt #1 was an 83 year old Alzheimers/dementia patient with increased evening wandering, hallucination and agitation that presented as pushing, shoving, slapping and/or kicking at staff who attempted to physically redirect him. Staff Psychiatrist #7 gave repeated telephone orders for the IM Ziprasidone (Geodon). The Physician's Desk Reference found at PDR.Net issues the following "Black Box" warning.


Dementia, geriatric, stroke

Lower initial doses of oral ziprasidone and careful dosage titration and observation are generally recommended for geriatric patients. Intramuscular ziprasidone injections have not been specifically evaluated in geriatric patients. Geriatric adults may be at increased risk for developing QT prolongation when using ziprasidone. Antipsychotics are not approved for the treatment of dementia-related psychosis in geriatric patients and the use of ziprasidone in this population should be avoided if possible due to an increase in morbidity and mortality in elderly patients with dementia receiving antipsychotics. Deaths have typically resulted from heart failure, sudden death, or infections (primarily pneumonia). An increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatal events, has also been reported. The Beers Criteria consider antipsychotics to be potentially inappropriate medications (PIMs) in elderly patients except for treating schizophrenia, bipolar disorder, and nausea/vomiting during chemotherapy. The Beers panel recommends avoiding antipsychotics in geriatric patients with delirium, dementia, or Parkinson's disease. Non-pharmacological strategies are first-line options for treating delirium- or dementia-related behavioral problems unless they have failed or are not possible and the patient is a substantial threat to self or others. If antipsychotic use is necessary in geriatrics with a history of falls or fractures, consider reducing the use of other CNS depressants and implement other fall risk strategies. Due to the potential for antipsychotic-induced hyponatremia and SIADH, sodium levels should be closely monitored when ziprasidone is initiated and after dose changes.

Pt #1 was admitted on the afternoon of 11/27/2021 and the first telephone order was obtained at 7:56 PM. Pt #1's MR confirmed staff RN #16 gave 10 mg of Ziprasidone at 8:13 PM IM to the left deltoid muscule.There was no further nuring documentation of assessment, evaluation or intervention attempted for pt #1's disruptive behavior. At "10:00 pm was taken to bed and fell asleep shortly thereafter". After putting pt #1 to bed there was no nurses entry of assessment or evaluation. The MR did not disclose if pt #1 was able to walk to his room after IM Ziprasidone or if he was taken via wheel chair. The Staff RN failed to document if pt #1 in any way resisted the staff or if he was cooperative.

Further review of nurses notes dated 11/28/21 - "8:05 PM Notified _______(Dr. #7, Psychiatrist) that patient was not being cooperative, very confused, insisting he needs to go home to take care of his parents. Does not want to sit in a chair in the activity room, does not want to go to bed. States, I need to get out of here, you need to let me out, I got to go home and take care of them. Unable to redirect patient. New order for Geodon 10 mg IM once now, if not effective give an additional 10 mg".

Review of the electronic clinical orders (Telephone) revealed the order was time stamped for 7:50 PM. Fifteen (15) minutes before the time stamp of 8:05 when Dr. #7 was notified. The documentation indicated the staff RN #16 wrote the telephone order at 7:50 PM, then notified Dr. #7 at 8:05 and at 8:32 PM gave 10 mg IM Ziprasidone. No behaviors were documented that were dangerous, either to himself or anyone else. No interventions were documented as attempted other than to redirect Pt #1 from being uncooperative, wandering and trying to find a way out.


On 11/28/2021 at 2103, (9:03 PM) staff RN #16 transcribed a second PRN order for IM Ziprasidone. The order read, "Ziprasidone 20 mg, this IM dose was the "if not effective give an additional 10 mg". The Staff RN failed to transcribe the route. The Staff RN documented at 11/28/2021 at 9:38 PM, on the medication administration record (MAR) Ziprasidone 10 mg given IM Left Deltoid.

On 11/29/2021 a review of the MAR identified staff RN #16 administered a 10 mg dose of IM Ziprasidone IM at 9:56 AM. A reviewof the electroic clinical orders identifed an order transcribed by staff RN #16 for Ziprasidone 10 mg timed 9:56 AM from Dr. #7. No nurses documentation was found to describe behavioral interventions attempted by the staff or specific behaviors for pt #1 that required IM Geodon.

On 11/29/2021 at 1225 (12:25 PM) staff RN #12 transcribed a telephone order from Dr. #7 for
Ziprasidone 20 mg, staff RN failed to transcribe a complete telephone order. The order failed to contain the route of administration and failed to include rational for the use of IM Geodon on an 83 year old dementia patient. The MAR confirmed at 12:32 PM Ziprasidone 20 mg was given Rt arm by staff RN #12.

Review of pt #1 MR confirmed on 11/29/2021 staff RN #16 documented "Patient is very confused, hallucinating, anxious, restless. Staff is unable to redirect him. He is a high fall risk, unsteady on his feet. Getting up out of bed, will not sit down in a chair in the activity room. Rambling and getting agitated with staff".
"1940 (7:40 PM) Dr. #7 notified and ordered Geodon 10 mg IM Now, give additional 10 mg if not effective in 30 minutes". The Now dose was not administered until 42 minute later.
"2022 (8:22 PM) Administered to left Deltoid, tolerated well".
"2138 (9:38 PM) First dose not effective, patient still climbing out of bed, wild eyed, hallucinating about somebody coming to get him. Two security guards in the room with him trying to calm him keep him safely in bed. Administered 2nd dose Geodon 10 mg IM to Right Deltoid, tolerated well".
11/29/2021 at 9:11 Dr. #7 signed an electronic order for Ziprasidone 10 mg Every 6 hoursPRN agitation.

Documentation confirmed Pt #1 received 10 mg over the recommended maximum dose of 40mg of IM Ziprasidone in a 24 hr period.

11/302021
Review of the MAR confirmed the following doses were given to Pt #1.
0955 staff RN #12 gave Ziprasidone 10 mg Left Arm.
0311 staff RN #17 gave Ziprasidone 10 mg Left Deltoid
Review of clinical orders revealed 0255 staff RN #19 transcibed a telephone order for Ziprasidone 20 mg

0012/9/2021
Review of the MAR confirmed that the following dose was given pt #1.
0023 staff RN #17 gave Ziprasidone 10 mg in left arm

Of the six 10 mg doses and two 20 mg doses of Ziprasidone order electronically, 7 total doses of Ziprasidone were documented on the MAR as given.




On 7/12/2022 the MR for patient #8 was reviewed. Patient is a 81-year-old white female with dementia. She is a nursing home resident. She is being admitted on a
transfer from Quitman ER with psychotic symptoms and aggressive behaviors.
She has visual hallucinations of people, intruders. She believes people are trying to harm her. She thinks the TV is talking to her. She is very confused and disoriented. She is irritable, hostile, uncooperative. She is refusing medications and refusing care. She resists assistance and is combative with caregivers. She is labile with mood swings and outbursts. She is not able to attend or concentrate. She is not able to follow directions. She is combative
with her caregivers. Sleep and appetite disturbances are also reported. Medical history -
Hypertension, diabetes mellitus, peripheral vascular disease, ischemic hepatitis, chronic kidney disease. Surgeries include cardiac surgery, heart stent, hip fracture with surgery, total abdominal hysterectomy. Pt #8 was not independently mobile.

Verbal medication orders provided by Psychiatrist #7 and Staff Licensed Vocal Nurse #11 are found below.

1.
Ziprasidone (GEODON) 20 mg/ml
Electronically signed: Staff #11, 07/03/22, 0310
Ordering user: Staff #11, LVN 07/03/22 0310
Frequency: 0310 - 1 occurrence
Medication comments: Created by cabinet override
(The review of the MR found no electronically signed order from Psychiatrist #7). This documentation implies the 1 time dose was administered.

2.
Ziprasidone injection 10 mg 07/03/22, 0311
Electronically signed by: Psychiatrist #7, MD on 07/04/22 1859
Ordering user: Staff RN #16, RN Telephone with readback mode
Ordering user:staff RN #16,
Frequency: Once 07/03/22 0300 - 1 occurrence
Although this order is documented with in 1 minute of the previous order, the corresponding nurses are not the same. There is no documented reason for giving the IM medication as a one time order.

3.
Ziprasidone injection 10 mg 07/04/22 0109
Electronically signed by: Psychiatrist #7, MD on 07/04/22 1859
Ordering user: Staff RN #16, Telephone readback order
Frequency: Once 07/04/22 0115 - 1 occurrence
There is no documented reason for giving an IM medication as a one time order.

7/3/2022 at 11:20 PM
Patient sitting in the gerichair in her room. She bent over and fell out of her chair head first. She was assisted back in to the chair by staff and assessed by this nurse. A large knot is noted to her right forehead and she has a skin tear to her right hand and to her left elbow. No other injuries noted. Dr #8 notified at 2130 and an order was received for a CT of the head without contrast. Patient was taken to the CT scanner by the house supervisor Tim and brought back to BHU afterwards. The patient's son Kim Thomas was notified of the fall at 2214. Patient remains in bed and is awake and alert at this time. She continues to be delusional and says that someone is going to kill her.

A review of the every 15 minute rounding sheet beginning at 11:00 am documented pt #8 in her room, in her bed, awake, with the bed alarm on. This was documented for 1 hour then from 12:00 to 1:00 the patient was in her bed awake.

Nursing documentation confirmed pt #8 had been placed in her room in a gerichair. She was not placed in her bed or assessed as the rounding sheet indicated.



On 7/15/2022 the MR for pt #9 was reviewed.
6/3/22 Patient is a 60-year-old white female with chronic mental illness and intellectual disability disorder. She is being admitted from nursing home with psychotic symptoms and behavior disturbances. She is very paranoid and delusional. She picking (sic) fights with other residents at the nursing home. She is irritable, hostile, and uncooperative. She is refusing medications. She is labile. She has mood swings and outbursts. She is yelling and cussing at staff
and residents at the nursing home. She is loud and disruptive. She is physically aggressive towards staff and she spits on people. She resists assistance and is combative with caregivers.

"6/7/2022, 5:01 PM
Problem #1 Aggression
B: Patient oriented to self and place. She was compliant today with medications. She is needy and demanding. When requests aren't met to her satisfaction, she screams and cries. This goes on until she tires out. She has to be coaxed out of her room for groups as she prefers to stay in bed.
I: Hourly rounding continued for patient safety. Commend patient for medication compliance. Redirected and reassured of safety and care. Encourage patient to attend groups and participate.
R: In dayroom eating dinner. Continues to be demanding.
P: Will monitor for medication effectiveness, fall risks and attempt redirection as needed."

"6/7/2022 9:53 PM
Refused snack, irritable and hollering out for a fan for her room. Denied need to use the bathroom when asked. Bed that she has been moved to the electronics are not working. Will switch beds when she needs to get up to go to the restroom. Door is open for observation.
R) Patient appears asleep, chest rise is even and unlabored.
P) Staff to continue to monitor for medication effectiveness every hour. Assess for fall and safety risks every 15 minutes. Reorient and redirect as needed."

"6/8/2022 4:13 AM
2315 Called Dr.#7 and new order for Geodon 10 mg IM once to help patient participate in her treatment program.
Behavior disturbance, threatening staff "I am going to shit on you", hollering out uncontrollably and not able to be redirected.
2320 Phone consent obtained from patient brother James Duncan.
2324 Administered Geodon 10 mg IM to L (Sic) shoulder. Tolerated well, no restraint required, held her Teddy bear.
0030 Patient appears asleep, chest rise even and unlabored.
0200 Patient awake and yelling, assisted to restroom."

New Geodon IM orders began on 6/7/2022. They are found below.
Ziprasidone (GEODON) 20 mg/ml
Electronically signed by: Morgan Martin, LVN on 06/07/22 2307
Ordering user: Morgan Martin, LVN 06/07/22 2307
Frequency: 06/07/22 2307 - 1 occurrence
Medication comments: Created by cabinet override
There was no electronic signature found for this order from Psychiatrist #7. There is no explanation for requiring the medication.

6/7/2022 7:00 AM
0636 Dr. Dr. #7 notified of patient acting out, hollering, being verbally abusive to staff and other patients. New order for Geodon 10 mg IM once to facilitate patient in participating in her treatment program.
0655 Administered Geodon 10 mg IM once to R deltoid. Tolerated well.

The order allows the nurse to administer a second dose within a 30-minute window without instruction to re-evaluate. It is the nurse's judgment as to whether the medication is effective. This is outside the scope of practice for a registered Nurse. The physician has given no behavioral parameters expected by the use of Geodon.

The review of the above patients confirms, the use of IM Geodon was used before, and preferred to oral medication efforts, staff 1:1 or even seclusion as viable options for treatment choices. Nursing documentation fails to assess any other patient attribute past loud, disruptive behavior. The facility used Geodon as a prefered treatment option, even though the Black Box warning strongly cautions against its use.

Based on record review and interview, the facility failed to

A. recognize that medications administered to restrain a patient behavior, resulting in restricting the patient's freedom of movement, was a Chemical Restraint/Emergency Behavioral Medication (EBM) administration and was prohibited to be written as a PRN (as needed) order in 1 of 1(#1) patient charts reviewed.

B. ensure patient safety when administering sedative and psychotropic medications to control immediate behavioral emergencies. The facility failed to recognize emergency behavioral medications were chemical restraints and not therapeutic treatment in 3 of 3 (#1, #3 and #6) patient charts reviewed.

C. ensure staff conducted comprehensive patient assessments with escalation of behavior to determine patient needs and interventions prior to the administration of chemical restraints/emergency behavioral medication, and continuous monitoring after administering a chemical restraint/emergency behavioral medication for side effects, respiratory or cardiac distress, and assessment of medication effectiveness and safety after administration in 3 of 3 (#1, 3 and 6) patient charts reviewed.

D. ensure a face-to-face evaluation was conducted following the administration of a chemical restraint/emergency behavioral medication to 3 of 3 (#1, #3 and 6) patient charts reviewed. The face-to-face evaluation should be conducted within 1 hour of the restraint to determine the patient's immediate situation, patient's response to the restraint, and patient's medical and behavioral condition.


Patient #3

Review of Patient #3's nurses notes revealed the Licensed Vocational Nurse(LVN) Staff #11 documented the following entry on 5/24/22 at 12:34AM.

"B: Pt in activity room at change of shift. She was agitated and pacing. She is confused and oriented to self only. She continuously tried to pull the covers off another patient and was agitating him. She stated, "That's my husband Bill, leave me alone!" Attempted to redirect patient and reorient her. She was difficult to redirect and was uncooperative. At this point she began exit seeking and setting off the door alarm. She was unwilling to take PO medication and stated that she would not be taking any more medication. Called Dr.___ (Staff #7) at 2119(9:19PM) and obtained an order for Ativan 1 mg IM once to enable adherence to treatment goals. Consent received from son, ____ POA, at 2122(9:22PM). Pt was reluctant but said "Do what you need to do." She allowed staff to give the injection. Medication was affective and pt is now asleep in her room with rise and fall of chest noted. Reassessment of vitals at 11:30PM BP 116/69 HR 76.
I: Reoriented and redirected, offered snacks, assisted with ADLs, bed in lowest position, call light on, yellow non-skid socks on, two side rails up.
R: Pt tolerated medication well and is now in bed sleeping with rise and fall of chest noted.
P: Will continue to monitor and intervene as needed."

Review of the physician orders revealed an order for Ativan 1 mg IM once. The medication was administered at 2151. There was no reason for administration on the order. The LVN described an unwanted behavior of agitation, pacing, exit seeking and setting off alarm doors. Patient was refusing po medications. The patient was administered a chemical restraint to control unwanted behaviors and actions. The medication was never addressed as a chemical restraint. There was no restraint packet in the chart, there was no nursing assessments after the administration, there was no documentation that an RN was even aware of the restraint being administered by an LVN, and there was no face to face performed. There was no evidence that this medication was part of the patient's daily medication regimen. The patient had refused all po medication. The LVN documented, "Pt was reluctant but said "Do what you need to do" and was administered the IM medication. The LVN documented vital signs 2 hours after the medication administration. There was no documented RN assessment found.

The patient had an OPC on the chart dated 5/20/22 there was no application or order for forced medications. Patient #3 still had the right to refuse medications and the facility was still required to obtain consents for psychotropic medications from the patient or administered as a chemical restraint/emergency behavioral medication (EBM) with safe processes in place.

Review of the physician orders dated 05/24/22 at 1810 "Ativan 1 mg IM once." There was no reason on the order for an administration of a chemical restraint.

Review of Patient # 3's nursing note revealed Staff #15 RN documented on 5/24/2022 at 1829. Staff #15 documented,
"Problem #1 Aggression
B: Patient was still sedated from injection last night until lunch. She stayed in the wheelchair and refused transfer to bed or recliner. She took morning medication at 1030 and remained cooperative until after lunch. She then began exit seeking and became uncooperative. Staff unable to redirect. She refused evening medication. After evening meal, she tried waking James and trying to get in bed with him. She started screaming she had the right to be there with him.
I:Hourly rounding continued for patient safety. Physician notified of patient's behavior. Physician stated offer evening medication again and if she refuses again, administer 1 mg ativan IM once TORB.
R: Medication administered to assist patient in accessing coping strategies. Administered without issue.
P: Will monitor for medication effectiveness, fall risks and attempt redirection as needed."

Review of the nurse's notes revealed there was no other de-escalation techniques attempted, or alternative measures documented before administering a chemical restraint. There was no further assessment of the patient or effectiveness of the restraint. There was no restraint packet, no face to face, or debriefing.

Review of the psychiatrist progress note dated 5/24/22 at 2104 stated, "Subjective
Patient is very confused and disoriented. She is distracted and disorganized. Her confusion worsens in the evenings. She thinks a male patient is her husband. She is very protective of him and prevents staff from helping him. She told staff that it is her husband "Bill". She is repeatedly going to his room and trying to get in bed with him. Gets agitated and aggressive when redirected. She is argumentative, yelling and screaming. She is restless, pacing and wandering. She is not able to stay still. She is exit seeking. Last night she was given Ativan IM with good response. Slept 6 hours. Appetite is fair. Needs prompting and cues with ADLs."
The psychiatrist described agitation and aggressive behaviors. The psychiatrist ordered a one-time sedative to control the patient's behavior. There was no found documentation that it was a chemical restraint nor was it a part of a therapeutic regimen.


Review of the nurse's notes revealed Staff #16 RN documented on 5/25/2022 at 0226,
"Problem #2 Potential for Falls
B) Patient is pacing in the hallways, trying to open doors, is intrusive with other patients going into their rooms, trying to wake up a the only male patient who is sleeping in the hallway. Irritable when staff tries to redirect and reorient. Cooperative with shift assessment. V/S's: BP 148/76, P 87, R 16, T 97.3, sats 93%. Unsteady with ambulation, received IM Ativan 1 mg at 1830.
I) She fell asleep sitting up in the activity room, was assisted to bed. Bed alarm on, side rails up x 2, non-slip socks on feet. Lighting adjusted; door cracked open for observation.
R) Patient is snoring, chest rise even and unlabored, no s/s of discomfort or distress.
P) Staff to continue to monitor for medication effectiveness every hour. Assess for fall and safety risk every 15 minutes. Reorient and redirect as needed."

Review of the chart revealed there was no assessment of Patient #3 after an administration of a chemical restraint until 7 hours later when an assessment and vital signs were documented.

Review of the policy and procedure of Restraint and Seclusion Behavioral Health Unit revealed a definition for a drug used as a restraint but does not address chemical restraints, emergency behavioral medication administration, assessments, or care after the administration of a chemical restraint.

Patient #1

Patient #1 was admitted to the facility for dementia with psychotic symptoms. He was an 83-year-old male. Review of the coding sheet upon discharge revealed Patient #1 was diagnosed with a history of Alzheimer's disease, Dementia in other diseases classified elsewhere with behavioral disturbance, Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, heart failure, and had a personal history of transient ischemic attack (TIA), and cerebral infarction without residual deficits. Patient #1 had multiple other co-morbidities.

Review of Patient #1's chart revealed an order for Geodon IM 10mg x1 on 11/27/21 at 1956. There was no reason documented on the order for medications. The medication was documented as administered at 2013.
Review of the nurse's notes dated 11/28/2021 12:43 AM the RN documented, "2005 Notified Dr.____ (Staff #7) that patient was not being cooperative, very confused, insisting he needs to go home to take care of his parents. Does not want to sit in a chair in the activity room, does not want to go to bed. States "I need to get out of here, you need to let me out, I got to go home and take care of them." Unable to redirect patient. New order for Geodon 10 mg IM once now, if not effective give an additional 10 mg. Also, can have Tramadol 50 mg for pain PRN every 6 hours.
2013 Administered Geodon to Left Deltoid with no combativeness. Tolerated well. Also took 2030 meds orally with no problems. 2132 Gabapentin he kept spitting it out but was successful in giving in some pudding.
2200 Was taken to bed and fell asleep shortly thereafter."

The nurse did not document that this medication was a chemical restraint to control the patient's behavior. There was no restraint package found. There was no found documentation of de-escalation techniques attempted, if p.o. medication was tried first, an assessment/reassessment of the medication effectiveness, or that a face to face was performed. There were no vital signs taken after the medication administration or an assessment of the patient respiratory system or cardiovascular system.

According to www.geodon.com Ziprasidone (Geodon) is a medication that works in the brain to treat schizophrenia. It is also known as a second-generation antipsychotic (SGA) or atypical antipsychotic. Ziprasidone rebalances dopamine and serotonin to improve thinking, mood, and behavior.

Ziprasidone (Geodon) had been linked with higher risk of death, strokes, and transient ischemic attacks (TIAs) in elderly people with behavior problems due to dementia. Increased Mortality in Elderly Patients with Dementia-Related Psychosis-Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Ziprasidone (Geodon) has a maximum daily dosage of 40mg per day.

There is no specific antidote to ziprasidone, and it is not dialyzable. The possibility of multiple drug involvement should be considered. Close medical supervision and monitoring should continue until the patient recovers.

Review of the nurse's notes dated 11/28/2021 0126 the RN documented, "
"B) Patient is restless, and uncooperative, does not want to sit in the activity room or go to bed. States "I got to go home and take check on my parents". Was able to sit him down and was cooperative with shift assessment. Lungs are clear to auscultation, pulses 2+, V/S's: BP 165/89, P 64, R 18, sats 94%. I) Took pictures per day nurse of cancer spots on bilateral ears. Obtained clean catch urine for lab. Reoriented and tried to redirect. (See previous nurse note). 2013 Geodon 10 mg administered. Assisted to bed, bed alarm on, side rails up x 2. Lighting adjusted; door open for observation across from nurse's station. R) Patient asleep, no s/s of medication side effects. Respirations even and unlabored. P) Staff to continue to monitor for medication effectiveness every hour, assess for fall and safety risks every 15 minutes. Redirect and reorient as needed. The nurse did not document vital signs for 5 hours after the medication administration.

There was no found nursing documentation of a nursing assessment and medication effectiveness every hour. A behavioral health technician (non-nurse) was monitoring every 15 minutes for behaviors and actions.

Two physician orders were found on 11/28/21 at 1947 and 2057 for Geodon 10mg IM once. There was no reason documented on the order for medications.

Review of the nurse's notes dated 11/29/2021 at 0010 stated, "Patient is very confused, hallucinating, anxious, restless. Staff is unable to redirect him. He is high fall risk, unsteady on his feet. Getting up out of bed, will not sit down in a chair in the activity room. Rambling and getting agitated with staff.
1940 Dr.____ (Staff #7) notified and ordered Geodon 10 mg IM now, give additional 10 mg if not effective in 30 min.
2022 Administered to Left Deltoid, tolerated well.
2138 First dose not effective, patient still climbing out of bed, wild eyed, hallucinating about somebody coming to get him. Two security guards in the room with him trying to calm him keep him safely in bed.
Administered 2nd dose Geodon 10mg IM to Right Deltoid, tolerated well.
30 minutes later patient finally settled down and Security was able to leave unit. Patient asleep soon after, respirations even and unlabored."

Nurses notes 11/29/2021 12:26AM Problem #2 Potential for Falls
B) Patient is restless, and uncooperative, does not want to sit in the activity room or go to bed. Was able to sit him down and was cooperative with shift assessment. States "My head is hurting; he is trying to kill me." Lungs are clear to auscultation, pulses 2+, V/S's: BP 159/87, P 81, R 20, sats 98%. Hallucinating and restless.
I) Staff tried to be reorient and redirect. (See previous nurse note).
1915 Tramadol 50 mg administered for headache. 1940 Geodon 10 mg administered. Assisted to bed, bed alarm on, side rails up x 2. Lighting adjusted; door open for observation across from nurse's station.
R) Patient asleep, no s/s of medication side effects. Respirations even and unlabored.
P) Staff to continue to monitor for medication effectiveness every hour, assess for fall and safety risks every 15 minutes. Redirect and reorient as needed."

Review of the psychiatrist progress notes dated 11/29/21 at 8:48PM the psychiatrist documented, " ...Last night he received Geodon IM for agitation. He was very restless, repeatedly trying to get out of bed, hallucinating, mumbling and getting agitated with staff. Today he received Geodon IM after lunch, he was very restless, tried to hit staff. He is compliant with oral medications ..." The psychiatrist documented that the patient was "compliant with oral medications". No evidence of oral medications for behaviors was documented as attempted first.

Review of patient #1's chart revealed the psychiatrist wrote an order on 11/29/21 at 2111 for Geodon "10 mg IM Every 6 hours PRN." There was no physician documentation that the ordered Geodon was used as a therapeutic medication for participating in the milieu but to control a behavioral outburst and agitation. There was no reason or scale on the order for why the nurse would administer this medication.

The registered nurse must follow physician orders with parameters for medications. The use of psychotropic medications written as PRN, or standing-order drugs, or medications is prohibited if the drug or medication meets the definition of a drug or medication used as a restraint.

Review of the Medication Administration Record revealed Patient #1 was administered Geodon 10mg on 11/30/21 at 0311 as a PRN order.

Review of the nurse's notes dated 11/30/2021 at 0320 revealed, "Patient awake and up in his room. He is agitated and trying to wake up his roommate. He was given Geodon 10mg IM left deltoid to support therapeutic interventions. Will monitor for effectiveness." There was no nursing documentation of trying oral medications to calm the patient before administering IM Geodon. The nurse did not document that this medication was a chemical restraint to control the patient's behavior(agitation). There was no restraint package found. There was no found documentation of de-escalation techniques attempted, if p.o. medication was tried first, an assessment/reassessment of the medication effectiveness, or that a face to face was performed. There were no vital signs taken after the medication administration or an assessment of the patient respiratory system or cardiovascular system. The nurse documented that she gave a PRN psychotropic medication for agitation.

Review of the nurse's notes dated 11/30/2021 at 0955 revealed, "Pt became aggressive with staff in the day room and hit and kicked 3 staff members, we attempted redirection with attempting to allow the pt to walk, pt remained aggressive and was given Geodon 10mg IM to facilitate therapeutic intervention. Pt did not resist injection. Staff will continue to redirect and monitor for medication effectiveness and fall risks. 1033 medication appears to have calmed the patient down at this time, he has been sitting at the table with staff and at this time has not attempted to get up without assistance nor has he attempted to hit staff again." Patient #1 was medicated again with IM Geodon as a PRN ordered medication for aggression. Nurse documented that she tried to redirect the patient but there were no other interventions documented before administering a chemical restraint. There were no vital signs taken after the medication administration or an assessment of the patient respiratory system or cardiovascular system. The nurse did not document that this medication was a chemical restraint to control the patient's behavior.

Agitation and aggression are not a medical diagnosis but a symptom with many variables from feeling nervous and restless to combative. Not all agitation or aggression would require an individual to be medicated.

According to https://medlineplus.gov/ency/article/003212.htm Agitation by itself may not be a sign of a health problem. But if other symptoms occur, it can be a sign of disease. Agitation with a change in alertness (altered consciousness) can be a sign of delirium. Delirium has a medical cause and should be checked by a health care provider right away."

There was no agitation scale or physician order found that defined agitation and the multilevel of agitation that would require a chemical restraint. A registered nurse must follow physician orders that provide an objective (not requiring the nurse to use medical judgement to interpret symptoms) scale or scoring system for PRN medications to stay within their scope of practice. Nurses were having to use medical judgement to determine if a patient should be medicated based on a symptom and not objective parameters identified by the physician within the order.

According to the "TEXAS BOARD OF NURSING CHAPTER 217
LICENSURE, PEER ASSISTANCE AND PRACTICE RULE §217.11
Standards of Nursing Practice
The RN does not perform medical diagnosis or prescription of therapeutic or corrective measures, unless licensed as an advanced practice registered nurse."

Patient #6
Review of Patient #6's chart revealed she was a 74-year-old female with Dementia with behavioral disturbance and hypertension. She was admitted to the facility on 05/07/2022 0115.

Review of Patient #6's chart revealed a physician order for Geodon 10mg IM on 05/09/22 11:58AM. There was no reason for use on the order. The medication was administered at 12:10PM.


Review of the Nurses note dated 5/9/22 at 3:51PM revealed,
"Problem #1 Aggression
B: Patient irritable and restless. She is medication compliant but uncooperative with patient cares. After being redirected multiple times she got agitated and started taking other patient's food items and belongings.
I:Hourly rounding continued for patient safety. Notified physician of behavior and Geodon 10 mg IM ordered to support therapeutic interventions.
R: Patient responded moderately to medication. She sat in dayroom calmly for several hours.
P: Will monitor for medication effectiveness, fall risks and attempt redirection as needed."
There was no restraint package found. There was no found documentation of de-escalation techniques attempted, if p.o. medication was tried first, an assessment/reassessment of the medication effectiveness, or that a face to face was performed. There were no vital signs taken after the medication administration or an assessment of the patient respiratory system or cardiovascular system.

Review of the physician orders dated 05/10/22 at 2:15AM revealed an order for Geodon 10mg IM once. There was no reason for use documented on the order. The medication was administered on 5/10/22 2:55AM.

Review of the Nurses notes dated 5/10/22 at 2:42AM stated,
"Patient woke up confused, says she wants to go to the bathroom, when shown the bathroom, she states "Don't tell me when to go pee. Get out of my house. She is yelling, slapping at, threatening staff. Dr. ___ (Staff #7) was notified and a new order for Geodon 10 mg IM once is ordered to facilitate patient in participating in her treatment program.
Patient did go to the restroom, 2 security guards arrived and held her in a strong hold for 10 secs. as nurse administered IM Geodon to Left Deltoid, Patient tolerated well. No bleeding noted.
Patient is wandering around in her room at this moment. She is fidgety, messing with blankets, pretending to clean. Talking to someone who is not in the room. Staff is watching through open door.
0320 Medication is effective. Patient has climbed into one of the beds in her room and appears to be Asleep, eyes are closed. Chest rise even and unlabored."

Patient #6 was forcibly held by two security guards to administer a chemical restraint for documented agitation and aggression. The nurse then documented that the patient did go to the bathroom as requested by the nurse but was still administered a chemical restraint against her will. There was no restraint package found. There was no found documentation of de-escalation techniques attempted, if p.o. medication was tried first, an assessment/reassessment of the medication effectiveness, or that a face to face was performed. There were no vital signs taken after the medication administration or an assessment of the patient respiratory system or cardiovascular system.

Review of patient #6's chart revealed she did not have vital signs taken after the administration of the Geodon until 6:20AM; 6.5 hours later. Patient #6's blood pressure was 181/113 (high) P 98. The nurse administered the patient's blood pressure medication. There was no documentation that the physician was notified.

An interview was conducted with Staff #2, #3, and #12 on 7/11/22. Staff #3 stated that she was the DPN on the unit for years but was now considered the Program Director of the mental health unit. Staff #3 did not have a job description for program manager. Staff #3 was shown the medications administered to Patient #1,3, and 6. Staff #3 stated that she did not think that was considered chemical restraints and thought it was ok to administer as therapeutic medications. Staff #3 had no clear understanding of a chemical restraint/emergency behavioral medication vs regularly ordered therapeutic medications. Staff #3 stated she was unaware of any PRN psychotropic medications ordered. Staff #3 stated she had not identified any issues with chemical restraints and there was no quality or monitoring of chemical restraints. Staff #3 confirmed the patients receiving IM psychotropics were not being added to the restraint log. Staff #12 stated that she was not aware that the psychotropic medications given IM for agitation and aggression were a chemical restraint. Staff #12 stated that she thought it was just to help therapeutically and was not looking at them as a restraint.


Staff #2 stated when chemical restraints/emergency behavioral medications are to be given in the facility that a restraint packet should be filled out. This would include the orders, face to face, debriefing and assessments. Staff #2 stated that she was unaware that the packets were not being utilized on the unit. Staff #2 stated that they are using the RASS score to determine agitation to administer medications.

The Richmond Agitation Sedation Scale (RASS) * The Richmond Agitation and Sedation Scale (RASS) is a validated and reliable method to assess patients' level of sedation and is an instrument designed to assess the level of alertness and agitated behavior in critically-ill patients in an intensive care unit. There is a description of behaviors and a score attached. According to that score a nurse can determine if the medication for sedation is appropriate or the patient or if the dose needs to be adjusted lower or higher according to the physician's scale or protocol. There was no found RASS score information or scale in the policy and procedure for Restraint or Seclusion for the behavioral health unit.

Based on record review and interview the facility failed to:

A. ensure the registered nurses evaluated and assessed changes in condition for 2 of 2 patient (patient #1 and #8) when Ziprasidone was administered as a new drug . This was evidenced by decline in independent ambulation, loss of continence of bowel and bladder and ability to feed and dress himself and loss of weight from 11/27/2021 through 12/13/2021 for pt #1 and a fall for patient #8 after the initiate dse of IM Geodon on 6/3/2022.

Refer to A 0395

B. ensure the Registered Nurses administered physician ordered medication and documented the doses according to the industry standards for 1 of 1 patient (#1) from 11/23/2021 through 12/2021.

Refer to A 0405

Based on interview and record review, the faculty failed to ensure the registered nurses evaluated, assessed and notified the physician and families of changes in condition for 2 of 2 patients (patient #1 and #8) when Ziprasidone was administered as a new drug. This was evidenced by decline in independent ambulation, loss of continence of bowel and bladder, ability to feed and dress himself, and loss of weight from 11/27/2021 through 12/13/2021 for pt #1. Patient #8 sustained a fall within 24 hours after the initial dose of IM Geodon on 6/3/2022.



This deficient practice had the likelihood to effect all patients of the Behavioral health Unit (BHU).

Findings included

On 7/11/2022 in the conference room, review of patient (Pt/pt)#1's medical record (MR) was completed with the assistance of staff #4. Pt #1 was admitted from his home by his wife. Pt #1 was an 83 year old male whose Alzheimer/dementia was progressing with increased confusion, evening restlessness, agitation and combativeness.

The review of pt MR confirmed the admitting psychiatrist had dictated, "pt #1 was alert to self, independent with feeding himself and continent of bowel and bladder". Pt #1's admission weight (wt) was documented as 157.48 pounds.

On 11/27/2021, pt #1 was admitted in time for his first meal. At 1831 hours (hrs) 6:31 PM, his intake was recorded as 90% and his nutrition was adequate with no nutritional risk indicators present.

On the evening of 11/27/2021, an order was received for intramuscular Ziprasidone (Geodon) 10 mg at 7:15 PM. The Intra muscular injection was delivered to pt #1 by staff RN #16.

Ziprasidone (Geodon) is not recommended for use in geriatric dementia patients even with behavioral manifestations. It carries a Black Box warning for caution for use in geriatric dementia patients. The use of this drug increases the demand on the registered nurse (RN) to regularly and systemically assess and evaluate the geriatric patient for more than behavioral conduct. Refer to the Physician Desk Reference (PDR.net) below.

"Dementia, geriatric, stroke

Lower initial doses of oral Ziprasidone and careful dosage titration and observation are generally recommended for geriatric patients. Intramuscular Ziprasidone injections have not been specifically evaluated in geriatric patients. Geriatric adults may be at increased risk for developing QT prolongation when using Ziprasidone. Antipsychotics are not approved for the treatment of dementia-related psychosis in geriatric patients and the use of Ziprasidone in this population should be avoided if possible due to an increase in morbidity and mortality in elderly patients with dementia receiving antipsychotics. Deaths have typically resulted from heart failure, sudden death, or infections (primarily pneumonia). An increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatal events, has also been reported. The Beers Criteria consider antipsychotics to be potentially inappropriate medications (PIMs) in elderly patients except for treating schizophrenia, bipolar disorder, and nausea/vomiting during chemotherapy. The Beers panel recommends avoiding antipsychotics in geriatric patients with delirium, dementia, or Parkinson's disease. Non-pharmacological strategies are first-line options for treating delirium- or dementia-related behavioral problems unless they have failed or are not possible and the patient is a substantial threat to self or others. If antipsychotic use is necessary in geriatrics with a history of falls or fractures, consider reducing the use of other CNS depressants and implement other fall risk strategies. Due to the potential for antipsychotic-induced hyponatremia and SIADH, sodium levels should be closely monitored when Ziprasidone is initiated and after dose changes."



Review of the medical record indicated pt #1 was admitted with Hypertension and atrial fibrillation (A-fib). The initial dose of IM Ziprasidone was documented on the orders sheet as "given 8:13 PM, Left Deltoid without resistance." Vitals signs were recorded at 3:56 PM on 11/27/2021. They were not recorded again until 2:11 AM on 11/28/2021. No other physical assessment or evaluation was identified. Review of the every 15 minute behavioral monitoring record indicated pt #1 slept from 12: 00 midnight until 12:00 noon the following day. No assessment was recorded. The psychiatrist documented pt #1 slept only 4.5 hours. No documentation was found that the physician or family had been made aware of the initial response to the first dose pf Geodon.

11/28/2021 Pt #1 woke up at 12:00 noon. Second and third dose of Geodon 10 mg was ordered and given at 8:32 PM and in at 9:39 PM. No vitals signs were recorded, and no documentation was identified of assessment or evaluation. Pt #1 ate 75% of 2 meals and less than 50% of one. Fluid intake was recorded for one meal. Continence was not documented. Pt #1 was awake until 9:30 PM and was documented as asleep until 9:30 Am the next day. The RN failed to capture the decrease in nutritional intake and failed to notify the physician or family.

11/29/21, the fourth dose of Geodon administered at 7:47 AM, this dose was a 20 mg dose. No vitals signs were recorded. No description of pt #1's behavior was documented. No interventions were documented. Pt's meal intake was documented as 0 intake for breakfast, 38% for Lunch, nothing was documented for dinner, but 100% of ice cream snack was documented. Although the patient accepted and consumed Ice Cream, in itself Ice Cream has no nutritional value. Pt #1 woke up at 9:30 AM and fell asleep at 10:00 Am until 11:30 AM. He remained awake until 5 and slept again until 5:30 PM. At 9:00 PM pt #1 fell asleep again. There was no nursing documentation regarding the lack of mobility, or the lack of nutritional intake.

11/30/021, the fifth and sixth dose of Geodon was administered at 3:11 AM. Review of the every 15 minute behavior monitoring log reflected documentation from 0200-0245 were pt #1 was up in the hallway, restless and agitated, irritable or loud. The sixth dose was documented as given at 9:56 AM. The staff documented the behavioral log that from 9:00-9:45 AM, Pt #1 was sitting with staff in the dining room with a yellow fall risk vest on. At 10:00, restless was included in the observation. No vitals signs were recorded for any of the doses. No description of pt #1's behavior was documented that indicated a danger to himself or other patients or staff, loud and irritable are not considered dangerous. No interventions were documented. Pt #1 nutritional intake was recorded as 100% at 10:28, 0% at 15:26 PM. No further liquid or nutritional solid intake was documented. The nursing staff documented less than one meal a day nutritional intake. The nursing staff continued to document no abnormal nutritional findings appetite within normal limits. There was no documentation the physician and the family were notified of condition changes.

12/1/2021, Pt #1's nutritional intake was documented as "17% Breakfast, 20% lunch, 118% (Sic) snack of ice cream and 25% of dinner". Nursing staff documented eating independently, without difficulty. Documentation indicated pt #1 was now incontinent and unsteady on his feet. Most of his time was spent in a wheel chair or in bed. Pt #1 slept 8 hours through the night.

12/2/2021 - nutritional intake was documented as 38%, 20% 118% snack of ice cream, and 25%. Pt #1's weight was not documented. Nursing staff continued to document, eating independently without difficulty.

12/3/2021, was documented as 25% with 240 milliliters (ml) of liquid, 50%, 236% (Sic) and 75% with 240 ml. Nurses documented, "No apparent abnormalities with eating, nutrition adequate."

12/4/2021, 120 ml liquid intake at 6:46 AM, 0% solid nutritional intake, 0% lunch and 0% dinner. 240 ml were recorded for lunch and dinner. No other intake notation was identified. The physician and the family were not notified and no documented changes were attempted in the patients plan care.

12/5/2021, 240 ml documented as liquid intake at 7:40 AM, 0% for lunch and 240 ml and 0% of snack, 0% for dinner. No intervention or notifications were identified in the MR. No nurse has documented anything unusual regarding pt #1.

12/6/2021 pt #1 wt. was taken and recorded at 145.14 pounds. This represented a 12.34 pound wt. loss in 9 days. The Registered Dietician was consulted and ice cream and milk shakes were added. A texture change to mechanical soft was introduced. Still the nursing documentation does not reflect assessment or evaluation of pt #1.

The above pattern was continued until the date of discharge. At that time pt #1 was wheel chair bound, incontinent of bowel and bladder, could not feed himself and could no longer rise from a sitting position without full assistance. His body wt was documented as 142.48.

During this Behavioral Heath Unit admission the nurses communicated with pt #1's wife once prior to pt being treated with intravenous fluids for rehydration on 12/12/2021. An interview with pt #1's wife revealed she had received, "a phone call from a nurse who told her pt #1 was gravely ill and might not survive, and she should contact the physician to allow an emergency visit".

The discharge summary dictated by psychiatrist #7 added an additional diagnosis of mild to moderate malnutrition.



On 7/12/2022 the MR for patient #8 was reviewed. Patient is a 81-year-old white female with dementia. She is a nursing home resident. She is being admitted on a
transfer from Quitman ER with psychotic symptoms and aggressive behaviors.
She has visual hallucinations of people, intruders. She believes people are trying to harm her. She thinks the TV is talking to her. She is very confused and disoriented. She is irritable, hostile, uncooperative. She is refusing medications and refusing care. She resists assistance and is combative with caregivers. She is labile with mood swings and outbursts. She is not able to attend or concentrate. She is not able to follow directions. She is combative
with her caregivers. Sleep and appetite disturbances are also reported. Medical history
Hypertension, diabetes mellitus, peripheral vascular disease, ischemic hepatitis, chronic kidney disease. Surgeries include cardiac surgery, heart stent, hip fracture with surgery, total abdominal hysterectomy. She is currently on Tylenol, atenolol, Keflex, colestid, vitamin B12, folic acid, Glucotrol, Xyzal, multivitamin, Protonix, Glycolax, potassium.

Verbal medication orders provided by Psychiatrist #7 and Staff Licensed Vocal Nurse #11 are found below.

1.
Ziprasidone (GEODON) 20 mg/ml ]
Electronically signed by: Morgan Martin, LVN on 07/03/22 0310 Status: Completed
Ordering user: Staff #11, LVN 07/03/22 0310 Ordering mode: Standard
Frequency: 0310 - 1 occurrence
Medication comments: Created by cabinet override
(The review of the MR found no electronically signed order from Psychiatrist #7). This documentation implies the 1 time dose was administered.

2.
Ziprasidone injection 10 mg 07/03/22 0311
Electronically signed by: Psychiatrist #7, MD on 07/04/22 1859
Ordering user: Staff RN #16, RN Telephone with readback mode
Ordering user:staff RN #16,
Frequency: Once 07/03/22 0300 - 1 occurrence
Although this order is documented within 1 minute of the previous order, the corresponding nurses are not the same. There is no documented reason for giving the IM medication as a one time order.

3.
Ziprasidone injection 10 mg 07/04/22 0109
Electronically signed by: Psychiatrist #7, MD on 07/04/22 1859
Ordering user: Staff RN #16, Telephone readback order
Frequency: Once 07/04/22 0115 - 1 occurrence
There is no documented reason for giving an IM medication as a one time order.

7/3/2022 at 11:20 PM
"Patient sitting in the gerichair in her room. She bent over and fell out of her chair head first. She was assisted back in to the chair by staff and assessed by this nurse. A large knot is noted to her right forehead and she has a skin tear to her right hand and to her left elbow. No other injuries noted. Dr #8 notified at 2130 and an order was received for a CT of the head without contrast. Patient was taken to the CT scanner by the house supervisor Tim and brought back to BHU afterwards. The patient's son Kim Thomas was notified of the fall at 2214. Patient remains in bed and is awake and alert at this time. She continues to be delusional and says that someone is going to kill her".

A review of the every 15 minute rounding sheet beginning at 11:00 am documented pt #8 in her room, in her bed, awake, with the bed alarm on. This was documented for 1 hour then from 12:00 to 1:00 the patient was in her bed awake. The rounding sheet did not indicate that a staff member was sitting in the room with her. The rounding sheets documented pt #8 never left her room.

Nursing documentation confirmed pt #8 had been placed in her room in a gerichair. She was not placed in her bed or assessed prior to her fall or after her fall. The every 15 minute rounding sheet indicated pt #8 was alone in her room prior to the fall and with staff in her room after the fall never leaving her room for the CT (computed tomography) scan or other evaluation.

Based on record review and interview, the facility failed to ensure the Registered Nurses administered physician ordered medication and documented the doses according the industry standards for 1 of 1 patient (#1) from 11/23/2021 through 12/2021.

This deficient practice had the likelihood to effect all patients of the Behavioral Health Unit of the hospital.

Findings included


On 7/11/2022 in the conference room, the medical record (MR) for patient (Pt/pt) pt #1 was reviewed. Further review of this MR occurred 7/13-14/2022 off site. The medication administration record indicated Staff Psychiatrist #7 ordered the following intramuscular (IM) dose of the medication Geodon.
1. Ziprasidone (Geodon) 11/27/2021 10 milligram (mg) dose IM once.
Documentation found on the Medication Administration record (MAR) confirmed this dose was given 11/27/2021 at 2013 (8:13 PM) by staff RN #16.
2. Ziprasidone 10 mg IM once 11/28/2021
Documentation found on the MAR confirmed this medication was given on 11/28/2021 at 2023 (11:23 PM) by staff RN #16.
3. Ziprasidone 10 mg IM once 11/28/21
Documentation found on the MAR confirmed this medication was given on 11/28/2021 at 2138 (9:38 PM)
4. Ziprasidone 10 mg IM every 6 hours PRN (Q6 hrs as needed) on 11/28/2021. This physician's order was not initiated until the following day.
Documentation found on the MAR confirmed Ziprasidone 10 mg was given IM 11/29/2021 at 0311(1:11 AM)
Documentation found on the MAR confirmed Ziprasidone 10 mg was given IM 11/29/2021 at
0956 (9:56 AM).
5. Ziprasidone 20 mg IM once on 11/29/2021..
Documentation found on the MAR confirmed this medication was given IM 11/29/2021 at 1232 (12:32 PM). Pt #1 reached 40 mg maximum dose in a 24 hour period.
6. Ziprasidone 10 mg IM (this order was not signed by staff Psychiatrist #7).
Documentation confirmed this medication was given on 12/9/2021 at 0023, (12:23 AM) by staff RN #16.

Review of the Staff Psychiatrist #7's daily notes and nurses notations of daily services and care provided to pt #1 indicated the following:

11/29/21 staff RN #15 documented; Dr. (#7) notified at 1940, Pt very confused, hallucinating, anxious, and restless. Staff unable to redirect him...
Order received for Ziprasidone 10 mg IM now and give an additional 10 mg in 30 minutes if not effect.
"2022 (8:22 PM) administered to Left Deltoid, tolerated well.
"2138 (9:38 PM) First dose not effective. Pt still climbing out of bed, wide eyed, hallucinating 2 security guards in the room with him trying to calm him and keep him safely in bed. administered 2nd dose of Geodon 10 mg IM right deltoid tolerated well." This documentation was electronically signed and timed by staff RN #15.

The above order does not correspond to times and dates of medication documented on the MAR. Patient #1 received 50 mg of Ziprasidone in a 24 hours period, 10 mg over the maximum dose.

The facility nurses failed to document 2 doses of IM Ziprasidone were given. No nurse documented the desired response because the Psychiatrist #7, failed to included the desired or expected outcome from the administration of IM Ziprasidone. The RN and psychiatrist were not aware of the maximum safe 24 hour dose of IM Ziprasidone had been met because the RN failed to document in the MAR and failed to document the order after it was given. The psychiatrist gave nursing staff two (2) separate PRN orders for Ziprasidone IM every 6 hours if needed for agitation. Pt #1's accumulative effect of repeated doses of Ziprasidone was not recorded in the clinical narrative.

Documentation on the MAR confirmed staff Psychiatrist #7 wrote 8 orders, that allowed 7 IM doses of Ziprasidone to be given IM to Pt #1.